Phase 3
Completed N=1,299
Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01387737 ↗Enrolled (actual)
1,299
Serious AEs
4.8%
Results posted
Apr 2014
Primary outcomePrimary: Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events — 81.8; 82.8; 14.9; 13.3 percentage of incidences
Summary
The purpose of this study is to evaluate the safety and efficacy of TA-7284 as monotherapy or combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type 2 diabetes mellitus on 52 weeks oral administration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events |
81.8; 82.8; 14.9; 13.3 | — |
| SECONDARY Change in HbA1c |
— | — |
| SECONDARY Change in Fasting Plasma Glucose |
— | — |
| SECONDARY Change in Body Weight |
— | — |
| SECONDARY Change in Blood Pressure |
— | — |
Eligibility Criteria
Inclusion Criteria
- Men or women age ≥20 years old
- Diagnosed with Type 2 diabetes mellitus at least 3 months before screening
- HbA1c of ≥7.0% and ≤10.0% (monotherapy group)
- HbA1c of ≥7.0% and ≤10.5% (combination therapy group)
Exclusion Criteria
- Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
- Past or current history of severe diabetic complications
- Fasting plasma glucose > 270 mg/dL before treatment start
- History of hereditary glucose-galactose malabsorption or primary renal glucosuria
- Patients requiring insulin therapy
Data sourced from ClinicalTrials.gov (NCT01387737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.